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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00615212 |
Purpose
This study is meant to assess potential inhibitory effects of GSK376501 on CYP450 isoenzymes 3A4, 2C8, 2C9. subjects will receive probe compounds and systemic levels of these substrates will be compared pre and post dosing of GSK376501.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: GSK376501 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | A Single Center, Single Sequence, Open-Label, Repeat-Dose Study to Investigate the Effect of GSK376501 on Hepatic Cytochrome P450 Activity in Healthy Adult Subjects |
| Enrollment: | 24 |
| Study Start Date: | January 2008 |
| Study Completion Date: | February 2008 |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | DIX110825 |
| Study First Received: | February 1, 2008 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00615212 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
GSK376501, Cytochrome P450 isoenzymes, Healthy Subjects, Repeat Dose |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |